Director, Statistical Programming

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Deliver technical programming strategies for complex studies, programs, and regulatory submissions.

• Offer technical guidance, mentoring, and peer consultation.

• Evaluate programming scope, complexity, required resources, critical-path activities, and delivery risks.

• Lead statistical programming for designated studies, development programs, and submission workstreams.

• Guarantee the completeness, accuracy, traceability, reproducibility, and regulatory preparedness of programming deliverables.

• Supervise outsourced programming, including specifications, deliverable reviews, issue resolution, risk tracking, and vendor accountability.

• Review electronic case report forms (eCRFs), annotated CRFs, data management plans, edit-check specifications, statistical analysis plans, dataset specifications, and TLF shells.

• Create and validate complex tables, listings, figures, nonstandard analyses, visualizations, and regulatory outputs.

• Collaborate with Biostatistics, Data Management, and other departments on clinical data compliance and Good Clinical Practice.

• Provide technical advice and training to programmers, medical monitors, scientists, and medical writers.

• Select and onboard CROs and contractors while managing assigned programming deliverables.

• Maintain inspection-ready programming documentation in accordance with SOPs and regulatory standards.

• Contribute to process definition, standards, automation, and implementation; author or revise SOPs, work instructions, templates, and technical guidelines.

• Monitor quality, timeliness, and vendor performance indicators, implementing corrective or preventive measures as needed.

• Communicate intricate programming, data, and submission issues to technical, cross-functional, executive, and regulatory stakeholders.

• Execute other duties as assigned.

⛳️ Requirements

• M.S. in Biostatistics, Computer Science, or a related field with a minimum of 10 years of experience in the pharmaceutical or biotechnology industry focused on statistical programming and clinical trial data analysis, or a comparable combination of education and experience.

• Significant hands-on experience with SAS programming.

• Proven track record as a senior technical individual contributor in leading complex studies, programs, or submission workstreams without formal people-management responsibilities.

• Expert-level proficiency in SAS programming, including advanced DATA step, SQL, macro programming, analysis procedures, debugging, performance optimization, and graphics production.

• Preferred experience across multiple phases of clinical development; early-phase and clinical pharmacology experience is a plus but not mandatory.

• Familiarity with 21 CFR Part 11, GCP, and regulatory requirements for validated systems, electronic records, traceability, and controlled programming environments.

• Experience with clinical data review and visualization tools is preferred.

• Highly desirable experience with R, Python, metadata-driven programming, or validated automation frameworks.

• Experience managing CRO and contractor programming deliverables, including scope definition, technical review, timeline and risk management, issue escalation, quality oversight, and final acceptance.

• Expertise in statistical programming practices and clinical data management processes, including robust quality control, independent validation, reproducible workflows, and inspection-ready documentation.

• Knowledge of clinical development and regulatory requirements, including NDA/BLA submissions, SDTM, ADaM, define.xml, annotated CRFs, reviewers guides, integrated summaries, submission TLFs, and regulatory information requests.

• Understanding of the roles within Biostatistics, Data Management, Clinical Development, Medical Writing, Regulatory Affairs, Pharmacovigilance, and Clinical Pharmacology.

• Demonstrated technical leadership and cross-functional influence.

• Capability to independently program, validate, troubleshoot, and deliver complex analyses and submission components under tight deadlines.

• Strong written and verbal communication skills.

• Ability to prioritize competing study, submission, and vendor deliverables.

🏝️ Benefits

• Equal employment opportunity employer.

• Protected Veterans/Individuals with Disabilities.

• Compliance with federal, state, and local employment law.